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IUDNCT06240260

TENS Unit for Analgesia During IUD Insertion

A study testing TENS (transcutaneous electrical nerve stimulation) unit in people with IUD and Analgesia, run by Tufts Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Subjects will be screened over the phone or in Tufts GYN clinic for participation in the study. If eligible and interested in participating, written informed consent (and assent if applicable) will be obtained. After informed consent/assent, the patient will be enrolled in the study. Read more about this study

Who is it for?
Ages 12 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
IUD, Analgesia, Patient Preference
What is being tested?
TENS (transcutaneous electrical nerve stimulation) unit
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
30 Apr 2024to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Persons with a uterus desiring insertion of intrauterine device
  • Able to provide informed consent/assent
  • Age 12-50 years old
  • Minors 12 years of age and older will be included in the study if postmenarchal

Who cannot join

  • Unable to provide informed consent/assent
  • Prior cervical procedure (ie loop electrosurgical excision procedure, LEEP)
  • Concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage)
  • Cutaneous damage at the TENS electrode sites
  • Chronic or pre-procedure use of opioids
  • Chronic pain diagnosis
Show all 15Show fewer
  • Prior IUD insertion
  • Any contraindication to intrauterine device (IUD):
  • Pregnancy
  • Uterine anomaly that distorts the uterine cavity
  • Acute pelvic inflammatory disease (PID)
  • Postpartum endometritis or infected abortion in the past 3 months
  • Unexplained abnormal uterine bleeding
  • Wilson's disease or copper allergy (contraindication to copper IUD only)
  • Breast cancer (contraindication to levonorgestrel IUD only

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Caitie McCarthy, MD contact

617-636-9897

caitlin.mccarthy@tuftsmedicine.org

United States1 site, 1 recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Alysa St. Charles, MA, 617-636-9897, alysa.st.charles@tuftsmedicine.org

    Andrea Zuckerman, MD

    Recruiting

Other trials in United States

About this study

Official title: Utilization of Transcutaneous Electrical Nerve Stimulation (TENS) Unit for Analgesia During IUD Insertion: A Prospective Cohort Study

Subjects will be screened over the phone or in Tufts GYN clinic for participation in the study. If eligible and interested in participating, written informed consent (and assent if applicable) will be obtained. After informed consent/assent, the patient will be enrolled in the study. The patient will decide if they desire to use TENS unit during IUD insertion appointment and inform the study team. The clinic visit will proceed as normal, with additional study proceedings as follows. The study personnel will complete the 'Background Questionnaire' with the patient prior to IUD insertion. During the IUD insertion appointment, study personnel will assist in collection of the 'Study visit' data collection form. This includes recording the patient's pain score at various time points throughout the insertion procedure:

  • anticipated pain during IUD insertion
  • baseline pain prior to insertion
  • speculum insertion
  • tenaculum placement
  • paracervical block administration (if performed)
  • cervical dilation (if performed)
  • uterine sounding
  • IUD insertion
  • 5 minutes after IUD insertion
Read more

Study personnel will also time the insertion procedure and collect additional data as outlined in the 'Study visit data collection form.' After IUD insertion, the participant will be asked to complete the 'Post-IUD Insertion Survey.' Once this survey is complete, this will conclude the study participation. Participation will last through the study visit only.

As part of the standard of care, a urine pregnancy test will be obtained and confirmed negative prior to IUD insertion. Patients will receive routine pain management modalities per shared decision-making with their clinical provider which may include NSAID administration, paracervical block, and heating pad.

Being tested
TENS (transcutaneous electrical nerve stimulation) unit, Standard care
Keywords
iud, contraception, iud placement, pain management, teen
Medical subject headings
Agnosia, Patient Preference, Acute Pain, Stillbirth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TENS (transcutaneous electrical nerve stimulation) unitDevice

    Also called TENS (transcutaneous electrical nerve stimulation) machine

    Transcutaneous electrical nerve stimulation (TENS) is a method of pain relief involving the use of a mild electrical current.

    A TENS machine is a small, battery-operated device that has leads connected to sticky pads called electrodes.

  • Standard careOther

    Paracervical block only or participant declines analgesia for IUD insertion

Study groups in NCT06240260
Study groupRoleWhat they receive
TENS unitExperimentalPatients who choose to use a TENS unit for their IUD insertion procedure
Receives: Device: TENS (transcutaneous electrical nerve stimulation) unit
Standard careActive comparatorPatients who decline to use a TENS unit for their IUD insertion procedure
Receives: Other: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self reported pain intensity from participants during IUD insertion

    Survey responses

    Measured: Day 1

Secondary outcomes (3)

  1. Pain at other time points during IUD insertion procedure

    Survey responses

    Measured: Day 1

  2. Rate of vasovagal responses

    Participant observation

    Measured: Day 1

  3. Likelihood to recommend pain management regiment to a friend for same procedure

    Survey responses

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2024
  2. Study start30 Apr 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06240260
Sponsor's protocol ID
STUDY00004077
Status last verified
Jun 2025
First submitted
27 Nov 2023
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Potter J, Rubin SE, Sherman P. Fear of intrauterine contraception among adolescents in New York City. Contraception. 2014 May;89(5):446-50. doi: 10.1016/j.contraception.2014.01.011. Epub 2014 Jan 21.

    PubMed 24560479

  • Asker C, Stokes-Lampard H, Beavan J, Wilson S. What is it about intrauterine devices that women find unacceptable? Factors that make women non-users: a qualitative study. J Fam Plann Reprod Health Care. 2006 Apr;32(2):89-94. doi: 10.1783/147118906776276170.

    PubMed 16824298

  • Fleming KL, Sokoloff A, Raine TR. Attitudes and beliefs about the intrauterine device among teenagers and young women. Contraception. 2010 Aug;82(2):178-82. doi: 10.1016/j.contraception.2010.02.020. Epub 2010 Apr 13.

    PubMed 20654760

  • Kavanaugh ML, Frohwirth L, Jerman J, Popkin R, Ethier K. Long-acting reversible contraception for adolescents and young adults: patient and provider perspectives. J Pediatr Adolesc Gynecol. 2013 Apr;26(2):86-95. doi: 10.1016/j.jpag.2012.10.006. Epub 2012 Dec 31.

    PubMed 23287602

  • Callahan DG, Garabedian LF, Harney KF, DiVasta AD. Will it Hurt? The Intrauterine Device Insertion Experience and Long-Term Acceptability Among Adolescents and Young Women. J Pediatr Adolesc Gynecol. 2019 Dec;32(6):615-621. doi: 10.1016/j.jpag.2019.08.004. Epub 2019 Aug 8.

    PubMed 31401254

  • ACOG Committee Opinion No. 735: Adolescents and Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Obstet Gynecol. 2018 May;131(5):e130-e139. doi: 10.1097/AOG.0000000000002632.

    PubMed 29683910

  • American College of Obstetricians and Gynecologists' Committee on Gynecologic Practice; Long-Acting Reversible Contraceptive Expert Work Group. Committee Opinion No 672: Clinical Challenges of Long-Acting Reversible Contraceptive Methods. Obstet Gynecol. 2016 Sep;128(3):e69-77. doi: 10.1097/AOG.0000000000001644.

    PubMed 27548557

  • Crawford M, Davy S, Book N, Elliott JO, Arora A. Oral Ketorolac for Pain Relief During Intrauterine Device Insertion: A Double-Blinded Randomized Controlled Trial. J Obstet Gynaecol Can. 2017 Dec;39(12):1143-1149. doi: 10.1016/j.jogc.2017.05.014. Epub 2017 Aug 18.

    PubMed 28826645

  • Nagatomo T, Tajiri A, Nakamura T, Hokibara R, Tanaka Y, Aono J, Tsuchihashi H. Adrenergic and serotonergic receptor-blocking potencies of terazosin, a new antihypertensive agent, as assessed by radioligand binding assay. Chem Pharm Bull (Tokyo). 1987 Apr;35(4):1629-32. doi: 10.1248/cpb.35.1629. No abstract available.

    PubMed 2888542

  • Mody SK, Kiley J, Rademaker A, Gawron L, Stika C, Hammond C. Pain control for intrauterine device insertion: a randomized trial of 1% lidocaine paracervical block. Contraception. 2012 Dec;86(6):704-9. doi: 10.1016/j.contraception.2012.06.004. Epub 2012 Jul 6.

    PubMed 22770792

  • Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434.

    PubMed 14622708

  • Rignon-Bret JM, Pompignoli M. [Esthetic presentation]. Inf Dent. 1987 Sep 24;69(32):2757-72. No abstract available. French.

    PubMed 3327829

  • Lison JF, Amer-Cuenca JJ, Piquer-Marti S, Benavent-Caballer V, Bivia-Roig G, Marin-Buck A. Transcutaneous Nerve Stimulation for Pain Relief During Office Hysteroscopy: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):363-370. doi: 10.1097/AOG.0000000000001842.

    PubMed 28079781

Questions about this trial

What is this clinical trial studying?

A study testing TENS (transcutaneous electrical nerve stimulation) unit in people with IUD and Analgesia, run by Tufts Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Caitie McCarthy, MD (617-636-9897, caitlin.mccarthy@tuftsmedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self reported pain intensity from participants during IUD insertion (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06240260, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.

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